Ice Miller's Food and Drug Administration ("FDA") practice encompasses a wide range of drug and medical device services including the provision of regulatory compliance advice, counseling institutional review boards and assisting clients in classifying medical devices and obtaining device exemptions and premarket approvals.

Our medical device practice specifically entails assisting clients with the following:

  • Medical device classification determination
  • Premarket 510(k) exemptions
  • 510(k) premarket notification
  • Substantial equivalency determination
  • Premarket approval of devices
  • Establishment registration
  • Medical device listing
  • Investigational device exemptions
  • Labeling compliance
  • Medical device monitoring and reporting
  • Good manufacturing practices and quality systems
  • Medical device recalls
  • Post-market surveillance
  • Response to FDA enforcement, including Warning Letters
  • Preparing for FDA inspections and audits
  • Preparing trade complaint letters about competitor activities
Clinical trials are a vital component of medical device development and manufacturing and present an array of challenges for medical device manufacturers. Ice Miller is able to assist with issues related to conducting, monitoring, auditing and reporting of clinical trials. Our auditing experience includes the use of statistical sampling methodology to ascertain variances, if any, between the prescribed protocols or process and actual results. We are knowledgeable and experienced in the special regulatory issues (both FDA and Department of Health and Human Services) and ethical issues surrounding the use of human subjects in clinical trials such as informed consent issues, good clinical practice guidelines, disclosure of financial interests of investigators, electronic signature compliance and protecting the confidentiality of the health information of trial participants.
 
Ice Miller attorneys have served as both members of institutional review boards (IRBs) and as counsel to individual IRBs, providing a diverse perspective on the issues faced by IRBs. These issues include:
 
  • IRB administration and composition of membership
  • Expedited review procedures
  • Study design
  • Recruiting research subjects
  • Adequacy of informed consent
  • Waiver of informed consent
  • Protection of special populations of subjects
  • Behavioral research
  • Privacy of research subjects and their health information
  • Continuing review of trials
  • Protocol development
  • Emergency use of unapproved devices
  • Payment of research subjects
  • Disclosure of financial relationships
  • Sponsor-Investigator relationships
  • Investigator-IRB relationships
  • IRB record retention and confidentiality
  • FDA inspections of IRBs

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